Recognize High Pressure Areas in Human Body to Prevent De... | NCT02173431

Studies
Recognize High Pressure Areas in Human Body to Prevent Decubitus Ulcers

NCT02173431

Sponsor

Assuta Medical Center

Status

Withdrawn

Last Update Posted

Mar 29, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Pressure Ulcer Stage 1

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
relation of pressure in gender	Registry Identifier	BMI and pressure mapping

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

due to technical issues

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Apr 10, 2014

First Submission Date that Met QC Criteria

Jun 23, 2014

First Posted Date

Jun 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2016

Last Update Posted Date

Mar 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prolonged external pressure to the tissue leads to compression, ischemia and development of pressure ulcer.

Underweight seems to be associated with high pressure ulcer risk but the distinct relation between overweight and pressure ulcer development is uncertain.

Bedsores are caused by pressure against the skin that limits blood flow to the skin and nearby tissue.

Others factors related to limited mobility can make the skin vulnerable to damage and contribute to the development of pressure sores. Three primary contributing factors are sustained pressure, friction and shear.

Bedsores are easier to prevent than to treat.

Detailed Description

age
weight
high
BMI
pressure scanning map
Alimentary status
Diseases

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMI 20 to 24.99		30 patients
BMI 25 to 29.99		30 patients
BMI 30 to 34.99		30 patients
BMI 35 to 39.99		30 patients
BMI 40 to 44.99		30 patients
BMI 45 to 49.99		30 patients
BMI more than 50		30 patients

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mapping body pressure	The patient need to rest above a mattress with sensors for pressure and the data is obtained by an specific software	up to 6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient admitted for elective surgery,
Patients above 18 y.o.,
Patient admitted for surgery that required 3 or more days in hospital

Exclusion Criteria:

Patients under 18
Patients that require emergency surgery
Patients that have bedsores before admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients from 18 y.o. before elective operation will be recruited for the study/ Any patient will be enroled in each group' seven in total according the BMI.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sergio G Susmallian, M.D.	ASSUTA MC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASSUTAMC		Tel Aviv		69710	Israel

Condition Browse Module

MeSH Terms

ID	Term
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided